Patent Docs

AstraZeneca and Dexcel Settle Suit over Delayed-release Omeprazole

    By Robert Dailey --

AstraZeneca and Israeli generic drug manufacturer Dexcel Pharma recently settled litigation involving the 20 mg delayed-release formulation of omeprazole (Prilosec®).  Under the agreement, Dexcel and its partner, Perrigo Company, will have the exclusive marketing rights to the store-branded OTC version of omeprazole.

In May 2006, AstraZeneca had filed suit against Dexcel after Dexcel filed a New Drug Application containing Paragraph IV certifications against three AstraZeneca  patents.  At the time of settlement, the district court had not yet made any substantive rulings in the case, although the parties had submitted a joint claim construction chart to Judge Farnan.

AstraZeneca has enjoyed over $700 million in sales of Prilosec OTC® within the past year.  The settlement will not immediately cut into this income stream, as Dexcel is still awaiting FDA approval of its NDA.  According to Perrigo (Dexcel's partner), FDA approval is expected near the end of Q1 in 2008.

This serves as an additional blow to AstraZeneca's efforts to maintain protection for various forms of Prilosec®.  Earlier this year, the Federal Circuit invalidated the patent covering the AstraZeneca's process for preparing its oral formulation (see "In re Omeprazole Patent Litigation (Fed. Cir. 2007)").

For additional information regarding this case, please see:

• Perrigo Company press release
• Pharmaceutical Business Review report

USPTO News: USPTO e-Commerce Update

    By Christopher P. Singer --

EFS-Web 1.2 Release

In an e-Commerce alert notice sent by e-mail on November 8, 2007, the USPTO announced that EFS-Web 1.2 should be released on November 11, 2007.  This update to EFS-Web will allow e-filers to:

• Use the newly available fillable Form SB16 - Provisional Application Cover Sheet;
• View important EFS-Web system messages on the first EFS-Web screen;
• Authorize over and under charges to deposit account when paying by credit card or deposit account;
• View acknowledgement receipts from the last 40 submissions (prior version allowed for prior 20 submissions);
• Receive more helpful warning messages when attaching documents;
• Select only from applicable fees on enhanced fee screen;
• Readily identify the desired filing option from the new login screen design; and
• Select from new Pre-Grant publication document descriptions.
  

PCT Requests in Applications Filed Using EFS-Web that Contain Sequence Listings

The USPTO also provided a link to instructional information relating to filling out the Request (conventional PCT/RO/101 & PCT SAFE/EASY) and Fee Calculation Sheet for international applications containing sequence listings or related tables that are filed with the RO/US via EFS-Web.  These instructions are believed necessary because neither of the Request forms have been modified to accommodate for international applications containing sequence listings that are filed using EFS-Web.  The document provides several examples of RO/101 Requests and PCT SAFE/EASY Requests that reflect the PCT recommendations for applications of certain length, with or without tables containing sequences, etc.

e-Office Action Pilot Program

The USPTO also announced that the e-Office Action Pilot Program has increased the number of notices it provides to participants.  Those participating in the pilot program now receive electronic notifications from the various Technology Centers (Office actions); the Office of Initial Patent Examination; the Office of Petitions; the Office of Patent Publication; the Office of License and Review; and the Board of Patent Appeals.

Post-GSK: Where Do We Go from Here? - Regional Patent Offices

    By Donald Zuhn --

The following is part of a continuing series on how to address the very real problems facing the U.S. Patent and Trademark Office.

A day after the day of rejoicing for inventors, patent practitioners, examiners, and seemingly all of civilization, fair-minded people will concede that the U.S. Patent and Trademark Office faces a daunting task.  After years of neglect - from Congress raiding the users' fees, an inadequate number of examiners, technology-driven increases in the number of applications filed, and a "count" system that has not rewarded a style of examination that encourages prosecution to a definitive end point - the Office is facing a massive backlog of applications without sufficient resources to process them in a timely manner.

If the patent bar is gladdened by District Court Judge Cacheris' decision enjoining implementation of the new rules - representing an attempt, albeit a misguided one, on the part of the Office to address the pendency and backlog problems - it behooves us to propose alternatives.  Patent Docs will be posting a series of such proposals, and we invite our readers to provide their own ideas.  As they used to say in the days of the counterculture, "if you are not part of the solution, you are part of the problem."  Patent Office management clearly thinks the patent bar is part of the problem; it would be satisfying to prove them wrong.

Regional Patent Offices

Yesterday, we reported on U.S. Patent and Trademark Office Deputy Director Margaret Peterlin's appearance before a Senate Subcommittee hearing on teleworking.  The Deputy Director spoke about the USPTO's Patent Hoteling program, a telecommuting program in which "hoteling" examiners spend most of their workweek at home and share offices called "hotels" when on the USPTO campus, and the Virtual Art Unit pilot program, in which the production of 13 hoteling patent examiners was found to compare favorably with that of 37 non-participating examiners on the Office's Alexandria campus.

More interesting, however, was Deputy Director Peterlin's statement that teleworking USPTO employees reside in Pennsylvania, New York, Illinois, North Carolina, South Carolina, Georgia, Colorado, Texas, West Virginia, and Delaware.  Since telecommuting USPTO employees are already spending the majority of their workweek in states as far west of the Alexandria campus as Illinois, Texas, and Colorado, one wonders why the Patent Office has been reluctant to take the next step and establish a number of regional patent offices.

By establishing regional patent offices, the USPTO could expand its pool of qualified examiner candidates to include individuals not living in or willing to relocate to the Washington, D.C. area.  And by expanding the pool of qualified examiner candidates, the USPTO could more readily accomplish its stated goal to ensure examination quality by "hiring the people who make the best patent and trademark examiners" (see "The 21st Century Strategic Plan").

While the Patent Office's 21st Century Strategic Plan contemplates further expansion of its teleworking programs, it does not address the establishment of regional offices.  However, because teleworking employees residing outside of Virginia are still required to report to the Alexandria campus at least once a week "to maintain the official duty station at USPTO headquarters," regional offices might also provide teleworking employees with a more proximate duty station (Patent Docs readers having more knowledge about this aspect of USPTO operations are invited to submit comments explaining why the Office must "maintain the official duty station at USPTO headquarters").

Deputy Director Peterlin, however, did provide clues about one alternative to regional offices during her testimony before the Senate.  In particular, the Deputy Director noted that the Patent Office has sought Congressional approval for a pilot program to allow teleworking employees to maintain their homes as official duty stations.  Thus, instead of establishing a handful of regional patent offices, the USPTO could effectively establish thousands of patent "offices" in which solo examiners go about the business of examining applications.  Either alternative would enable the Patent Office to attack the growing application backlog with the only weapon we know will work: an expanded corps of qualified examiners.

For additional articles in the "Post-GSK" series, please see:

• "Tailoring Protection and Examination," November 6, 2007
• "Annuities," November 1, 2007

Industry Trilateral Group and the "Global Patent Application" Project

    By Christopher P. Singer --

On November 7, 2007, the Industry Trilateral Group, which includes the Intellectual Property Owners Association (IPO), the American Intellectual Property Law Association (AIPLA), Business Europe, the Japan Intellectual Property Association (JIPA), and practitioner groups the European Patent Institute (epi) and the Japan Patent Attorneys Association (JPAA), published a report that outlined several suggested rule and statutory changes as part of a "Global Patent Application" project.  The report cites to data from the Trilateral Offices (USPTO, EPO, and JPO) that was used to estimate that the annual costs associated with modifying patent applications as they are filed in patent offices across the world approach $300 million.

The group identifies five changes it believes would have the most pronounced effect on reducing these costs, and create progress toward some harmonization.  These changes include:

• Removing National Legends (US) - This refers to the requirement in the U.S. that applications must contain sections such as "Cross-Reference to Related Applications" and "Statements of Federal Sponsored Research."  Since these sections are particular to the U.S. and need to be removed upon filing in Europe and Japan (and must be added to original EP and JP applications when filed in the US), these sections would not be required in the filed patent specification.

• Including Reference Numerals in Abstract & Claims (US) - This relates to a suggested change in the U.S. that would require that reference numerals appearing in the abstract or claims could not be used to limit claim scope.

• Removing Requirement of Conformance of Specification & Claims (EP) - This proposed change addresses the requirement in Europe that the specification contains language that conforms with the language of the allowed claims.

• Requiring Amendment of the Specification to cite Prior Art (EP) - This proposed change would preclude the EPO from requiring that a description of the prior art applied during prosecution be inserted into the specification.

• Citation of Prior Art (JP) - This proposal would change current Japanese practice of citing specific prior art references in the specification, and allow for the citations to be made in a separate paper.

Age-related Macular Degeneration Patients Get a (Limited) Reprieve

    By Kevin E. Noonan --

Responding to outrage, protest, and threats of political and legal action, or perhaps just belatedly recognizing that it was in the middle of a public relations nightmare, Genentech last week announced that it would delay until the end of the year implementation of its decision to "no longer allow compounding pharmacies to purchase Avastin® directly from drug wholesalers," a ban that was originally set to begin on November 30, 2007.

Genentech's decision is related to the use of the company's anticancer drug, Avastin® (bevacizumab, a monoclonal antibody), for neovascular or "wet" age-related macular degeneration (AMD), a condition that if untreated leads inexorably to blindness.  This is an off-label use; another Genentech drug, Lucentis® (ranibizumab injection), has been approved for AMD treatment.  The choice of the off-label use is related to the cost differential between the drugs:  Avastin® treatment costs from $20-60 per dose, while Lucentis® treatments cost $2,000/dose.  Since neither drug is a cure for AMD, patients require maintenance doses substantially for the remainder of their lives.  The cost differential is due to both differences in cost (Avastin® is priced at only $600/vial) and because the drug is injected into the eye at such small doses (0.1cc) that each vial of Avastin® can deliver 30 doses ($20/dose).

Genentech's announcement was based, at least in part, on FDA concerns over sterility and packaging of the reformulated Avastin®, and concerns that Avastin® had not been "designed, manufactured or approved" for the off-label use (see "Genentech Acts to Halt Off-label Use of Avastin® for Age-related Macular Degeneration").  It is apparent that Genentech management feels justified in charging more for Lucentis® due to the company's extensive testing and regulatory efforts (and costs) to establish safety and efficacy of the drug for AMD (see "Genentech CEO Defends Differential Cost for Avastin®/Lucentis® Treatment of Macular Degeneration").

The retinal community responded negatively to the news that Genentech planned to cut off the source of Avastin® to formulating pharmacies, which provided a safe and reliable source of the reformulated drug.  In particular, the American Society of Retinal Specialists (ASRS) organized their members, sending them information regarding the effects of the ban, and protested Genentech's actions to the company, in letters threatening that the organization was "actively investigating the legality, cost, and ramifications of options open to its membership to keep Avastin available to our patients . . . in conjunction with the American Association of Ophthalmologists and other groups."  Importantly, ASRS reminded its members that Avastin® was expected to remain available until next spring and from hospital pharmacies even after the ban is put into place.

Now, in news provided by Dr. Edward Chaum (at left), Plough Foundation Professor of Ophthalmology, University of Tennessee, Genentech and ASRS had a conciliatory meeting with very positive results that were reported to the membership in an e-mail update.  First, Genentech has delayed its proposed ban until January 1, 2008, and consequently Avastin® is expected to be available until at least next summer.  Also, the ASRS representatives meeting with Genentech company officials, including Genentech CEO Dr. Arthur Levinson (at right), had a better understanding of the circumstance surrounding the decision to ban sales to formulating pharmacies.  These included an incident with an FDA inspector that resulted in the company destroying four lots of Avastin®, corresponding to 382,000 vials (or almost 10 million AMD doses) at a cost of more than $200 million.  The ASRS update stated that "there was indeed reason for Genentech to consider the continuation of sales to compounding pharmacies a potential serious liability for the company, and that a reasonable business person might have come to the same decision about limiting sales."

As a consequence, the "bad guy" role has been shifted to the FDA.  The ASRS reports that Senator Herb Kohl (D-WI) of the Senate Special Committee on Aging scheduled a teleconference with FDA representatives and members of the American Association of Ophthalmologists (AAO).  Genentech has agreed that "if the FDA will no longer raise issues with them about providing Avastin to compounding pharmacies, they will lift the embargo on sales to these pharmacies."

The update ends on a positive note:

In summary, our recommendation to the ASRS membership is that we go forward in good faith and with appropriate caution, and continue our efforts to marshal the resources of the medical, regulatory, and pharmaceutical industries to ensure that our patients maintain access to the treatments they need.  This is not to say that we will always agree with industry and the FDA --- we serve different masters, and our missions, while similar, are not always exactly aligned.  Physicians have no responsibility to stockholders, nor does the FDA govern our relationship with our patients.  But perhaps we can agree to be open-minded, and to communicate.

For additional information on this topic, please see:

• "Genentech Acts to Halt Off-label Use of Avastin® for Age-related Macular Degeneration," October 21, 2007
• "Genentech CEO Defends Differential Cost for Avastin®/Lucentis® Treatment of Macular Degeneration," June 6, 2007
• "Retinal Specialist on the Avastin®/Lucentis® Controversy," February 23, 2007
• "Lower Doses of Genentech's Avastin® Effective in Treating Lung Cancer," February 23, 2007

Post-GSK: Where Do We Go from Here? - Tailoring Protection and Examination

    By Kevin E. Noonan --

The following is part of a continuing series on how to address the very real problems facing the U.S. Patent and Trademark Office.

A day after the day of rejoicing for inventors, patent practitioners, examiners, and seemingly all of civilization, fair-minded people will concede that the U.S. Patent and Trademark Office faces a daunting task.  After years of neglect - from Congress raiding the users' fees, an inadequate number of examiners, technology-driven increases in the number of applications filed, and a "count" system that has not rewarded a style of examination that encourages prosecution to a definitive end point - the Office is facing a massive backlog of applications without sufficient resources to process them in a timely manner.

If the patent bar is gladdened by District Court Judge Cacheris' decision enjoining implementation of the new rules - representing an attempt, albeit a misguided one, on the part of the Office to address the pendency and backlog problems - it behooves us to propose alternatives.  Patent Docs will be posting a series of such proposals, and we invite our readers to provide their own ideas.  As they used to say in the days of the counterculture, "if you are not part of the solution, you are part of the problem."  Patent Office management clearly thinks the patent bar is part of the problem; it would be satisfying to prove them wrong.

Tailoring protection and examination to the needs of particular technologies

The Patent Office has applied the Patent Act uniformly to technologies having different needs for patent protection.  For example, biotechnology and pharmaceuticals need strong patent protection that, maybe more importantly, lasts long enough for the patentee to recoup large development and regulatory compliance costs.  Prosecution times (for a family of applications including continuations) must be sufficiently long for an applicant to have time to obtain the information necessary to determine which species of a (typically) large genus will be the commercial product.  Although this strategy is consistent with the business needs of the biotech and pharma industries, Patent Office management (and some academic commentators) have used it to demonize these applicants, contending that they are not entitled to patent protection if they don't "know" what their "invention" is when an application is filed.  This view overlooks the public benefit of early disclosure of the broadest and most detailed specification, and seems rooted in another time when a patent term was fixed by patent grant date, rather than earliest filing date.  Also echoed in these concerns are "submarine patent" issues which have largely disappeared because U.S. patents are published and prosecution of published patents is open to the public.  The shenanigans facilitated in the past by such outdated practices have largely been eliminated by these earlier changes in U.S. patent law.

On the other hand, other technologies have very different patent needs, some of which have been either explicitly addressed by the Office or have formed the rationale for the ill-considered "new rules."  These include the needs to rapid access to patent protection, requiring reduced pendency times and exacerbated by the current backlog.  Arts affected by these considerations include software and the computer-related arts, where factors such as Moore's Law result in rapid obsolescence times for these technologies.  There are also significant differences between these arts and the biotech and pharma industries with regard to investment costs, and whereas different pharmaceutical companies can develop different compounds that have the same or equivalent biological activity (e.g., different statins or antibiotics) and thus provide distinctly-different paths for patent protection, information technology companies can encounter a "patent thicket" of different technologies protected by patentees who are individual inventors, or worse, companies who have acquired patents from individual inventors (the dreaded "trolls").

These differences are ill-served by a "one-size-fits-all" system of patent protection.  One solution, suggested previously (see "Could Creating a U.S. 'Utility Model' Patent Fulfill the 'Need' for Patent Law Reform?"), is for an applicant to be able to opt for something akin to the utility model patent in Europe.  Under this scheme, an applicant could choose examination limited to novelty, utility, and adequacy of disclosure, and the Office would forego examination based on obviousness.  Such a petty-patent scheme would have a more limited term, anywhere from 5 to 10 years, with maintenance fees assessed according to a more frequent schedule (every one or two years).  Examination of these patents would thus require less Patent Office resources and could incorporate other Office initiatives, such as accelerated examination and peer-to-patent prior art submissions (which would be more focused if obviousness is not a consideration).  Limitations on remedies, such as precluding injunctive relief or providing for compulsory licensing, could also be adopted.

Limiting protection (at an applicant's option) in return for accelerated examination and patent grant would provide these applicants with patent protection commensurate with their value.  They would provide a means for protecting the type of incremental advances disparaged by the Supreme Court in KSR Int'l Co. v. Teleflex, Inc., advances of a kind that can make the difference in adapting older technologies to new developments by providing the appropriate modicum of protection to spur investment (considerations not addressed by the Supreme Court).  Limited term would encourage patentees to permit technology to more rapidly fall into the public domain as it became less advantageous to the patentee, a long-standing goal of the patent system.  And limitations on damages would ameliorate the "patent thicket" effects of independently patented, small variations, and improvements, while at the same time reducing the "litigation jackpot" incentive for companies to invest in patents solely for the purpose of suing the members of a high-tech industry.

For additional articles in the "Post-GSK" series, please see:

• "Annuities," November 1, 2007

Deputy Director Peterlin Testifies at House Hearing on Teleworking

    By Donald Zuhn --

Deputy Under Secretary of Commerce for Intellectual Property and Deputy Director of the U.S. Patent and Trademark Office Margaret Peterlin (at right) testified today at a House of Representatives hearing on teleworking.  The hearing, entitled "Telework: Breaking New Ground?" was held by the Subcommittee on Federal Workforce, Postal Service, and the District of Columbia, which is part of the House Committee on Oversight and Government Reform.  In view of the Patent Office's 750,000 application backlog and the Office's attempts to reduce this backlog by promulgating its draconian continuation and claims rules, the Deputy Director's comments regarding the success of teleworking programs at the USPTO offer some insight into a rather painless way to increase Office efficiency.

Deputy Director Peterlin testified that as of October 19, 2007, 3,609 USPTO employees -- or 40.7% of the Patent Office's workforce -- participated in some form of teleworking.  The Deputy Director noted that after initiating the Trademark Work-at-Home (TWAH) program in 1997, the Patent Office expanded its teleworking program to include patent examiners with the creation of the Patent Hoteling program in 2006.  The Patent Hoteling program is a flexible telecommuting program in which participating examiners spend most of their workweek at home.  When working on the Office's Alexandria campus, however, the examiners in this program share offices called "hotels," which can be reserved on-line before the examiners come onto the campus.  The program, which originally involved 500 examiners, has since been expanded to 1,000 examiners, and the Deputy Director stated that Office plans to have 3,000 examiners involved in the program by 2011.

Deputy Director Peterlin noted during her testimony that "[t]he nature of our patent and trademark examination work easily lends itself to employee telecommuting," an important observation at a time when the Office's application backlog continues to grow.  The Deputy Director also stated that teleworking leads to a happier and more productive workforce since examiners gain an "improved work/life-family balance" and "add[] hours of 'found time' to an otherwise hectic and exhausting day" by reducing commuting and "commuting anxiety."  More importantly, the USPTO's teleworking program has allowed the Office "[to] improve overall employee retention -- thus reducing the costs of recruiting and training associated with high staff tumover rates."

Interestingly, the Deputy Director noted that the Office already has teleworking employees residing in Pennsylvania, New York, Illinois, North Carolina, South Carolina, Georgia, Colorado, Texas, West Virginia, and Delaware.  However, because these employees "are currently required to report to the office at least once per week to maintain the official duty station at USPTO headquarters," the USPTO has sought Congressional approval for a pilot program to allow these employees to maintain their homes as official duty stations.  For those advocating that the Office establish satellite offices, this pilot program could constitute the first step.

Deputy Director Peterlin concluded her testimony by discussing the results of a recent Virtual Art Unit pilot program in which the production of 13 hoteling patent examiners was compared with that of 37 non-participating examiners on the USPTO campus.  As with prior Office teleworking pilot programs, the office found that the hoteling examiners had a 10% increase in production, doubled their amount of overtime, and yielded quality reviews that were not significantly different from the non-participating examiners.

For additional information on this topic, please see:

• USPTO press release regarding the Deputy Director's appearance at the hearing

The Wall Street Journal Gets It Half Right

    By Kevin E. Noonan --

Claude Barfield and John E. Calfee of the American Enterprise Institute opined on the Op-Ed page of The Wall Street Journal last Monday, discussing the wisdom (or lack of it) in patent "reform" bills pending in Congress.  While generally consistent with an informed appreciation of the benefits of the patent system, the piece is also littered with the type of patent myths and half-truths that have become all too familiar to anyone acquainted with the treatment of patent issues in the popular press.

First, the good news.  The authors caution Congress against using the blunt instrument of legislation where fine-tuning by the Patent Office and the Courts may lead to a better result.  This is the case, according to Barfield (at left) and Calfee (at right), with regard to patent damages, where they assert the Federal Circuit is coming to a more nuanced appreciation of how to properly apportion damages in patent cases.  They also cite Patent Office rules in biotechnology that have focused on enhancing the quality of the disclosure necessary to support claims to biological materials.  And they correctly identify Congressional raiding of Patent Office users' fees as the real culprit behind the difficulties the Office is currently experiencing with the backlog of pending applications.

They argue that Congress should concentrate its efforts on proposals that have broad support, such as adopting a "first to file" system and a post-grant opposition procedure.  However, while commending the proposed opposition procedure for having provisions limiting the timing of such oppositions (to prevent them from being oppressive to patentees), they ignore provisions requiring Europe and Japan to adopt a "grace period" like our own for a patentee's own disclosure before "first to file" is adopted.

In some instances, they just get it wrong.  They castigate the Federal Circuit for being too pro-patent, forgetting the erosion of the doctrine of equivalents under the Court (to the extent that provoked Supreme Court oversight to, one presumes, the Federal Circuit's regret) and the evolution of increasingly stringent application of the written description requirement in biotechnology inventions.  Their biggest gaffe is to characterize reexamination of WARF's human embryonic stem cell patents as taking steps to "revoke three embryonic stem-cell patents because they duplicated already published research and similar patents."  The fact of the reexaminations is true; the rest closely approaches fantasy (see "It's Time to Stop the Hypocrisy over Stem Cell Patents").

There is one point made by the authors that rings particularly true in the week after the GSK decision.  Writing about the provisions of patent "reform" legislation that would retroactively validate Patent Office authority to engage in substantive rulemaking, they write that such efforts "are notably ill-considered, particularly [the] one to grant new substantive rule-making authority to the USPTO.  Given the current disarray within the agency and its continuing struggle to master the challenges of emerging technologies, giving it even greater authority just now would be extremely unwise."

For additional information on this topic, please see:

• "BIO CEO Provides Briefing on Follow-On Biologics and Patent Reform," September 18, 2007
• "Patent 'Reform' Bill Passes House of Representatives," September 9, 2007
• "San Francisco Chronicle Opines on Patent Reform," August 6, 2007
• "Patent Reform Bill to Be Delayed?" June 12, 2007
• "Senate Judiciary Committee Holds Hearing on Patent Reform," June 10, 2007

Pharmaceutical Res., Inc. v. Roxane Labs., Inc. (Fed. Cir. 2007)

    By Donald Zuhn --

On October 26th, the Federal Circuit affirmed a District Court's finding on summary judgment that certain claims of U.S. Patent Nos. 6,593,318 (the '318 patent) and 6,593,320 (the '320 patent) were invalid under 35 U.S.C. § 112, first paragraph, for lack of enablement.

The '318 and '320 patents are directed to stable flocculated suspensions of megestrol acetate (see below) and methods for making such suspensions.  Seeking to design around a patent owned by Bristol-Myers Squibb (BMS) and directed to stable suspensions of megestrol acetate, Plaintiffs-Appellants Pharmaceutical Resources, Inc. and Par Pharmaceuticals, Inc. (Par) discovered that flocculated suspensions of megestrol acetate could be formed using a wider array of ingredients (i.e., surfactants and wetting agents) and concentrations than disclosed in the BMS patent (the BMS patent discloses only one stable flocculated megestrol acetate suspension).  Par received a number of patents for its flocculated megestrol acetate suspensions, including the '318 and '320 patents.

Par brought suit against Defendant-Appellee Roxane Laboratories, Inc. (Roxane) in 2003, asserting that Roxane infringes certain claims of the '318 and '320 patents.  Following the District Court's Markman order, Roxane moved for summary judgment of invalidity, arguing that the '318 and '320 patent were invalid for lack of enablement.  The District Court granted Roxane's motion for summary judgment of invalidity, finding that "as a matter of law Par is not entitled to the broad claims it asserts in this action."

On appeal, the Federal Circuit determined that "[t]he scintilla of evidence put forward by Par to suggest that the claims are enabled, most of which actually conflicts with the intrinsic evidence in this case, does not raise a genuine issue of material fact."  In particular, the Federal Circuit noted that both the '318 and '320 patents disclosed that "[t]he surfactants in a stable flocculated suspension need to be selected carefully and be used within a critical concentration range because even minor changes can have an effect on the properties of such a stable formulation."  However, the Federal Circuit found that while Par's patents describe the unpredictability of flocculated megestrol acetate suspensions, the patents disclose only three working examples, utilizing only one surfactant not described in the BMS patent.

The Federal Circuit also noted that the extrinsic evidence supported a conclusion that the preparation of flocculated megestrol acetate suspensions is unpredictable.  For example, "Dr. Chao, a named inventor of the '318 and '320 patents, testified that predictions could not be made regarding whether or not particular combinations of ingredients including megestrol acetate would form a stable flocculated compound, but rather, this required actual experimentation."

In rejecting Par's argument that its own experiments with megestrol acetate are sufficient to create a genuine issue of material fact regarding enablement, the Federal Circuit concluded that given the teachings in the patent about the criticality of the choice of surfactant and concentration:

the extraordinarily broad scope of the claims, which encompasses hundreds of surfactants, the high degree of unpredictability of the art, and the minimal guidance provided by the three working examples in the specification, the mere fact that Par's inventors were able to create successfully a stable flocculated megestrol acetate suspension with seven surfactants does not create a genuine issue of material fact regarding enablement.

Thus, the Federal Circuit determined that the asserted claims of the '318 and '320 patents were invalid under 35 U.S.C. § 112, first paragraph, for lack of enablement.

Pharmaceutical Res., Inc. v. Roxane Labs., Inc. (Fed. Cir. 2007)
Nonprecedential disposition
Panel: Chief Judge Michel, Circuit Judge Moore, and District Judge Cote
Opinion by Circuit Judge Moore

Additional information regarding this case can be found at the Orange Book Blog and Patently-O.

Court Report

    By Sherri Oslick --

About Court Report:  Each week we will report briefly on recently filed biotech and pharma cases, and a few interesting cases will be selected for periodic monitoring.

Celgene Corporation et al. v. Barr Laboratories, Inc. et al.
2:07-cv-05256; filed October 31, 2007 in the District Court of New Jersey

Infringement of U.S. Patent Nos. 5,837,284 ("Delivery of Multiple Doses of Medications," issued November 17, 1998) and 6,635,284 (same title, issued October 21, 2003) (both assigned to Celgene and licensed exclusively to Novartis in certain fields of use) following a paragraph IV certification as part of Barr's filing of an ANDA to manufacture a generic version of Novartis' Ritalin® LA (methylphenidate hydrochloride extended release capsules, used to treat attention deficit hyperactivity disorder/attention deficit disorder).  View the complaint here.

Elan Corporation PLC et al. v. Actavis South Atlantic LLC
1:07-cv-00679; filed October 29, 2007 in the District Court of Delaware

Infringement of U.S. Patent Nos. 6,228,398 ("Multiparticulate Modified Release Composition," issued May 8, 2001) and 6,730,325 (same title, issued May 4, 2004), licensed to Novartis, following a paragraph IV certification as part of Actavis' filing of an ANDA to manufacture a generic version of Novartis' Focalin® XR (extended release dexmethylphenidate hydrochloride, used to treat attention deficit hyperactivity disorder).  View the complaint here.

Medeva Pharma Suisse A.G. et al. v. Roxane Laboratories, Inc.
3:07-cv-05165; filed October 26, 2007 in the District Court of New Jersey

Infringement of U.S. Patent No. 5,541,170 ("Orally Administrable Pharmaceutical Compositions," issued July 30, 1996) following a paragraph IV certification as part of Roxane's filing of an ANDA to manufacture a generic version of plaintiffs' Asacol® (mesalamine, used to treatment ulcerative colitis).  View the complaint here.

Aventis Pharmaceuticals Inc. et al. v. Dr. Reddy's Laboratories, Ltd. et al.
2:07-cv-05180; filed October 26, 2007 in the District Court of New Jersey

Infringement of U.S. Patent Nos. 6,399,632 ("Method of Providing an Antihistaminic Effect in a Hepatically Impaired Patient," issued June 4, 2002), 6,187,791 (same title, issued February 13, 2001), and 6,037,353 (same title, issued March 14, 2000), 6,113,942 ("Pharmaceutical Composition for Piperidinoalkanol Compounds," issued September 5, 2000), 5,855,912 (same title, issued January 5, 1999), and 5,738,872 (same title, issued April 14, 1998) following a paragraph IV certification as part of Dr. Reddy's filing of an ANDA to manufacture a generic version of Aventis' Allegra-D® 24 Hour (fexofenadine hydrochloride/ pseudoephedrine, used to treat allergies).  View the complaint here.

Sepracor Inc. et al. v. Perrigo Research And Development Company et al.
3:07-cv-05136; filed October 25, 2007 in the District Court of New Jersey

Infringement of U.S. Patent Nos. 7,214,683 ("Compositions of Descarboethoxyloratadine," issued May 8, 2007) and 7,214,684 ("Methods for the Treatment of Allergic Rhinitis," issued May 8, 2007), licensed to Schering-Plough, following a paragraph IV certification as part of Perrigo's filing of an ANDA to manufacture a generic version of Schering-Plough's Clarinex® (desloratidine, used to treat allergies).  View the complaint here.

Conference & CLE Calendar

November 8, 2007 - Trilateral Cooperation: Successes, Opportunities, and Challenges (Intellectual Property Owners Association) - Washington, D.C.

November 13-15, 2007 - Pharma and Biotech Collaborative Agreements (American Conference Institute) - New York, NY***

December 3, 2007 - 18th Annual Conference on U.S. Patent and Trademark Office Law and Practice - PTO Day (Intellectual Property Owners Association and U.S. Patent and Trademark Office) - Washington, D.C.

January 9, 2008 - Patent Claim Construction (Law Seminars International) - San Francisco, CA

January 30-February 1, 2008 - Pharma/Biotech IP Due Diligence (American Conference Institute) - New York, NY***

February 15, 2008 - Patent Claim Construction (Law Seminars International) - Chicago, IL

***Patent Docs is a media sponsor of this conference or CLE.

LSI Patent Claim Construction Workshops

Law Seminars International (LSI) will be holding two one-day workshops on Patent Claim Construction on January 9, 2008 in San Francisco, CA and on February 15, 2008 in Chicago, IL.  The workshops will cover key issues in claim construction, including a case law overview and update, recent developments from the Federal Circuit, litigation strategies, and effective appellate advocacy.  In particular, each workshop will offer presentations on the following topics:

• Current Federal Circuit Developments in Claim Construction
• Litigation Strategies from Plaintiff and Defendant Perspectives
• Adapting to the Changes in the Law: Tips for Successful Claim and Specification Drafting: Implications of Patent Office Rule Changes
• Views From the Bench
• In-House Strategies for Addressing the Key Issues in Claim Construction Today: Managing the Prosecution Process for the Most Effective Claim Drafting on a Portfolio-wide Basis
• Using Graphics to Help Win Claim Construction Disputes
• Handling Claim Construction on Appeal

An agenda for the San Francisco workshop can be found here.  A complete brochure for the San Francisco workshop, including an agenda, list of speakers, and registration form can be downloaded here.

An agenda for the Chicago workshop can be found here.  A complete brochure for the Chicago workshop, including an agenda, list of speakers, and registration form can be downloaded here.

The registration fee for each workshop ranges from $347.50 (students and new employees) to $695 (regular tuition).  Discounts are available for government employees and groups of two or more registrants.  Those interested in registering for the San Francisco workshop can do so here and those interested in registering for the Chicago workshop can do so here.

IPO PTO Day

Last week, we reported that the Intellectual Property Owners Association (IPO) and the U.S. Patent and Trademark Office will be co-sponsoring the 18th Annual Conference on U.S. Patent and Trademark Office Law and Practice (PTO Day) on December 3, 2007 in Washington, D.C.  At the time, a program for the conference was not yet available.  The IPO has now released a program for the conference.  The patent portion of the conference will address the following topics (although it will be interesting to see whether some of the scheduled topics will change in view of the recent decision in the consolidated cases of Tafas v. Dudas and SmithKline Beecham Corp. v. Dudas):

• Introduction and State of Patent Operations
• Understanding the New Patent Rules on Continuations and Claims
• Strategies for Operating Under the New Patent Rules on Continuations and Claims
• USPTO Guidelines for Determining Obviousness in View of the Supreme Court Decision in KSR International Co. v. Teleflex Inc.
• Federal Circuit Opinions Affecting USPTO Patent Practice: Key Cases of the Past Year
• Current Intellectual Property Rights Developments (Luncheon Presentation by Commissioner for Patents John Doll)

Patent-related breakout sessions will address the following topics:

• Questions and Answers on the Continuations and Claims Rules
• Practicing Before the Board of Patent Appeals and Interferences
• Professional Responsibility for Intellectual Property Practitioners

The registration fee for the conference ranges from $200 (government/academic) to $600 (general registration).  Those interested in registering can do so here.  While the program indicates that there will be a live webcast of the conference, the online listing notes that the live webcast has been cancelled.

Post-GSK: Where Do We Go from Here? - Annuities

    By Kevin E. Noonan --

A day after the day of rejoicing for inventors, patent practitioners, examiners, and seemingly all of civilization, fair-minded people will concede that the U.S. Patent and Trademark Office faces a daunting task.  After years of neglect - from Congress raiding the users' fees, an inadequate number of examiners, technology-driven increases in the number of applications filed, and a "count" system that has not rewarded a style of examination that encourages prosecution to a definitive end point - the Office is facing a massive backlog of applications without sufficient resources to process them in a timely manner.

If the patent bar is gladdened by District Court Judge Cacheris' decision enjoining implementation of the new rules - representing an attempt, albeit a misguided one, on the part of the Office to address the pendency and backlog problems - it behooves us to propose alternatives.  Patent Docs will be posting a series of such proposals, and we invite our readers to provide their own ideas.  As they used to say in the days of the counterculture, "if you are not part of the solution, you are part of the problem."  Patent Office management clearly thinks the patent bar is part of the problem; it would be satisfying to prove them wrong.

Annuities

To start things off, consider the advantages of requiring an annuity payment to keep an application pending.  This device is used in many countries, particularly in Europe, to encourage applicants to maintain only those applications pending that are considered worth the cost of the annuity.  Adapting this concept to the American patent system would require a few modifications, however.  Small entity applicants would be exempt from the requirement, so as to not put individual inventors, universities, and small businesses at a disadvantage.  Divisional applications would require an annuity based on a schedule starting not at the priority date but on the filing date.  This would be consistent with divisional applications having claims to patentably-distinct inventions, and not the result of strategic decision-making by the applicant that could be manipulated to extend pendency.  What must be avoided is the requirement in Europe that a continuation or divisional application pay the accumulated annuities previously paid in the parent case, which would represent a significant disincentive to serial divisional filing and would exacerbate the backlog problem by encouraging "early" divisional filing.

An additional advantage of this proposal is that it would increase Patent Office revenues in a way tied directly to applicants who file and maintain multiple related applications.  Since the Patent Office contends that these applicants are responsible for increased pendency and the backlog, the annuity would have these applicants pay for the privilege.  An added benefit would be that over time some of the more controversial assumptions the Patent Office made with regard to the new rules would be put to the test, since it would be expected that if a significant portion of continuation applications represent "gaming the system" or planting potential traps for competitors, adding a cost to the process should shift the cost/benefit analysis in the direction of discouraging unnecessary continuation filings.